Avoid common mistakes in sterile line and reduce risk of pharmaceutical producti

2018-09-11 17:57:42

The more important requirement of the bacteria production line is that all components of the production line should be kept in a sterile state, including the connection device and supply system of the production line. Only in the overall design and manufacture of sterile production line, each part meets the sanitary design requirements, and the corresponding technical specifications can be guaranteed.

It is understood that some mistakes will inevitably occur in the sterile production line, which will bring serious consequences to the production, and also make the sterile production line unable to better meet the purpose of use and production requirements. In fact, in the design and operation of sterile line, some mistakes can be effectively avoided.

Avoiding corners, for example, is a tenet in pharmaceutical manufacturing equipment, but actually it's not easy to avoid corners altogether, and you have to pay attention to valve installation. Experts say valves should be installed as far as possible to avoid dead corners. In addition, ensure that the sealing film and bellows do not bear large pressure impact. The blind Angle of hygiene should also be avoided during the inspection of instruments and the inspection of the installation of sensors.

Industry personage also expresses, hang down conduit also can be prevented effectively. If the pipe is laid horizontally and at a slight slope, water will flow in the sagging concavity due to the pipe's dead weight. This droop is usually hard to detect with the naked eye.

This kind of water can appear when the equipment starts, the pressure drops in the production pipeline phenomenon, this also becomes the canning wave one big reason. For this reason, if relevant personnel find sufficient suspension device and appropriate slope, such error can be effectively avoided, because proper spacing of suspension device can avoid pipe droop.

At present, the sterile production line of the pharmaceutical equipment enterprise is used in the production of the biological toxicity product solvent clean raw material medicine. The production line is equipped with a high quality isolation system, providing sterile assurance at the core of the pharmaceutical process and controlling the effects of product toxicity on people and the environment. In addition, the customized design is also adopted in the core areas from ingredients to aseptic production (three in one, crushing, and packaging), which is in line with the development trend of high-end drug production technology.

From the perspective of layout, the workshop layout is strictly implemented according to the current relevant regulations and standards of the state. Under the conditions of meeting fire control requirements and industrial safety, the layout within the workshop area can be ensured to be reasonable and compact. According to the sequence of production process, the boundary area is clear and orderly, saving land as much as possible, saving investment and improving economic efficiency.

In the process of feeding, the material of the production line is imported from the net, weighed in the isolator, and fed through vacuum transportation. The surplus material is sent out through RTP barrel. The isolator is equipped with CIP/WIP cleaning function and integrated vaporization hydrogen peroxide function to effectively control the impact of product toxicity on personnel and environment.

In terms of cleaning and sterilization of packaging materials, the packaging materials are also transported by means of integrated connection. Aluminum barrels are cleaned and sterilized automatically and transferred to the isolator after sterilization, thus effectively isolating the inconvenient transportation and docking risks of traditional laminar flow vehicles. In addition, the aluminum barrel can be parallel in and out, the ultrasonic cleaning time will be greater than or equal to 3 minutes, the output speed will be greater than or equal to 1 barrel per minute, and the cleaning time of each aluminum barrel can be adjusted.

Every mistake in a sterile line is a unique mistake, but some mistakes are usually made in the design and maintenance of the line, which is not a problem at first, but can bring huge risks to the whole production process. To avoid these mistakes, companies need to be thoughtful in their design and production to provide customers with more advanced sterile lines.